DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicants elected a composition of cyclosporine A at between 1-999 µM, tacrolimus at a concentration of 20-100 nM, water, and tragacanth with traverse in the reply filed on 21 July, 2025. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 13 Aug, 2025.
Applicants argue that claim 11 should be examined. However, as noted in the previous office action, cyclosporine is not soluble in water in significant amounts. It should also be noted that applicants were required to elect a formulation; they did not elect any formulation with the limitations of claim 11.
Claims Status
Claims 1-18, 20, and 21 are pending.
Claims 1-16, and 18 have been amended.
Claims 20 and 21 are new.
Claims 3, 4, 8-13, 17, and 18 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 6 and 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty if the concentrations referred to the sum of the calcineurin inhibitors or each one individually is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14, and claims dependent on it, require a gel, while withdrawn claims require a cream or a lotion. Applicants have not defined these terms, so the dictionary definitions (Merriam Webster online dictionary) are used. Gel is defined as a gelatinous preparation, cream is defined as something having the consistency of cream, and lotion is defined as a liquid preparation for cosmetic or external medical use. Note that these are rather squishy definitions, and are not sufficient to determine if a given embodiment falls into one or another of the possible materials. This renders the claims indefinite.
response to applicant’s arguments
Applicants argue that the terms “gel,” “cream,” and “lotion” are well known and understood in the art.
Applicant's arguments filed 12 Feb, 2026 have been fully considered but they are not persuasive.
It is agreed that the terms are commonly used in the art, but based on the disclosure, it is not clear when a formulation stops being a gel and becomes a cream, in applicant’s claims (for example). Nor has applicants pointed to any definition that unambiguously show if a given formulation reads on a “gel” as required by the claims, rather than a cream or a solid.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7, 14, and 15are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lipari et al (US 20170266289).
Lipari et al describe formulations of cyclosporine at 0.01, 0.1, and 1% w/w (example 5, paragraph 358). These were prepared according to example 3 (paragraph 358), which describes mixing the pharmaceutical with water, oil, and SEPINEO P600 (examples 1 and 2, paragraphs 295-315). SEPINEO P600 is a gelling or thickening agent (paragraph 159). This reasonably reads on a gel. Note that, while the reference does not discuss using these formulations as a contraceptive, what is claimed is the formulation, not a method of using it. So long as the formulation is suitable for the claimed intended use, it will read on the claims (MPEP 2122). Nor is there anything in the formulation that is clearly irritating or unsuitable for gonadal application. Thus, this reference anticipates claims 1, 2, 14, and 15. Note that 0.01% is 83 µM and 0.1% is 830 µM, so this reference anticipates claims 7, 20, and 21.
response to applicant’s arguments
Applicants argue that the rejection does not meet the intended use limitation, and that it has not demonstrated suitability for intravaginal or scrotal application.
Applicant's arguments filed 12 Feb, 2026 have been fully considered but they are not persuasive.
As noted in the rejection, for a formulation, the limitation of an intended use is merely if the formulation is suitable for the intended use. There is nothing in the formulation that clearly makes it unsuitable. Note that the thickener SEPINEO P600, is suggested for vaginal use (pharmaexcipients.com press release for SEPINEO P600, (2024) https://www.pharmaexcipients.com/news/sepineo-p600-seppic/ , 4th page, 1st paragraph), and the other ingredients in the formulation (water, oil, therapeutic) are not obviously problematic.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 5-7, 14-16, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lipari et al (US 20170266289) in view of Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
Lipari et al describe synthesizing topical formulations (abstract) that comprise oil, water, and an emulsifier (paragraph 6-10). Cyclosporine A is explicitly described as an active ingredient that can be used to treat psoriasis, alopecia, vitiligo, keratosis, itching, and atopic dermatitis (paragraph 201). An additional therapeutic can be added to the formulation, which can be tacrolimus (paragraphs 275 and 280 – note that FK506 is a synonym for tacrolimus). Tragacanth is a member of a Markush group of emulsifying agents (paragraph 157). An example of cyclosporine gels at 0.01, 0.1, and 1% w/w is given (example 5, paragraph 358). These were prepared according to example 3 (paragraph 358), which describes mixing the pharmaceutical with water, oil, and SEPINEO P600 (examples 1 and 2, paragraphs 295-315). SEPINEO P600 is a gelling or thickening agent (paragraph 159).
Please note that this reference anticipates claims 1, 2, 6, 14, and 15.
While this reference describes the limitations of claim 5 (cyclosporine and tacrolimus), and 16 (gelling agent), these are selected from different lists, making the relationship between this reference and these two claims a better fit for obviousness than anticipation.
The difference between this reference and the remaining claim is that this reference does not give the concentration of the tacrolimus.
Le Tourneau et al states that the main goal of phase I clinical trials is to establish the dose and dose schedule for new drugs or drug combinations (abstract). The idea is to avoid unnecessary exposure of patients to subtherapeutic doses of the drug, while preserving safety and assuring rapid accrual (p708, 1st column, 2nd paragraph). A number of experimental schemes are given to optimize these dosages (fig 2, p711, top of page). This reference discusses how to optimize doses of drug mixtures.
Therefore, it would be obvious to optimize the dose of the calcineurin inhibitors of Lipari et al, to avoid unnecessary subtherapeutic doses while minimizing toxicity and ensuring rapid accrual of the drug, as described by Le Tourneau et al. As this optimization must be done for every drug used, an artisan in this field would be very familiar with these protocols, leading to a reasonable expectation of success. Note that the mechanism of action of the drugs for the utility of Lipari et al and those of applicants is the same (calcineurin inhibition), so the dosages would be expected to be comparable.
response to applicant’s arguments
Applicants repeat the same arguments as with respect to the rejection under 35 USC 102, which were answered there. They further argue that Le Tourneau et al is limited to cancer, not contraception, and that the dosages are not suggested by the cited references.
Applicant's arguments filed 12 Feb, 2026 have been fully considered but they are not persuasive.
While Le Tourneau et al is concerned about cancer clinical trials, applicants have provided no argument as to why the teachings of that reference would not be applicable to their invention, esp. as optimizing a dose is the same problem for any drug.
Applicants further argue that the doses are not given by the prior art. This is not true; it is given by optimization, with a note that the mechanism is the same as the prior art references, so the amount should be comparable. Note that the total dose is the concentration times the amount used; so the optimum concentration is dependent on the dosing amount, which is not defined.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658